EUCREAS 50850 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

METFORMIN HYDROCHLORIDE; VILDAGLIPTIN

متاح من:

NOVARTIS ISRAEL LTD

ATC رمز:

A10BA02

الشكل الصيدلاني:

FILM COATED TABLETS

تركيب:

VILDAGLIPTIN 50 MG; METFORMIN HYDROCHLORIDE 850 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

NOVARTIS PHARMA AG.,SWITZERLAND

المجال العلاجي:

METFORMIN

الخصائص العلاجية:

Eucreas is indicated in the treatment of type 2 diabetes mellitus:- Eucreas is indicated in the treatment of adult patients who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone or who are already treated with the combination of vildagliptin and metformin as separate tablets.- Eucreas is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled with metformin and a sulphonylurea.- Eucreas is indicated in triple combination therapy with insulin as an adjunct to diet and exercise to improve glycaemic control in adult patients when insulin at a stable dose and metformin alone do not provide adequate glycaemic control.

تاريخ الترخيص:

2017-03-31

نشرة المعلومات

2
EUC SPL Sep22 V3
EU PIL 07.2022
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS'
REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
EUCREAS®
50/500 MG
EUCREAS®
50/850 MG
EUCREAS®
50/1000 MG
Film-Coated Tablets
Film-Coated Tablets
Film-Coated Tablets
COMPOSITION:
Each tablet contains:
Eucreas 50/500 mg: vildagliptin 50 mg and metformin hydrochloride 500
mg.
Eucreas 50/850 mg: vildagliptin 50 mg and metformin hydrochloride 850
mg.
Eucreas 50/1000 mg: vildagliptin 50 mg and metformin hydrochloride
1000 mg.
INACTIVE INGREDIENTS: See section 6 “Further Information”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet
contains concise information about the medicine. If you have further
questions, contact
the doctor or pharmacist.
This medicine has been prescribed to treat your disease. Do not pass
it on to others. It
may harm them even if it seems to you that their disease is similar to
yours.
1. WHAT IS THE MEDICINE INTENDED FOR?
Both active ingredients are oral antidiabetic agents.
Eucreas is intended for treatment of type 2 diabetes: Eucreas is
intended for treatment in
adults already receiving combined treatment with separate tablets of
vildagliptin and
metformin hydrochloride, or whose diabetes is not adequately
controlled with metformin
hydrochloride alone.
Your doctor will prescribe Eucreas either alone or in combination with
another diabetic
medicine depending on your condition. Eucreas can also be taken in
combination with
insulin or with a medicine from the sulfonylurea group, by adults,
together with diet and
exercise.
THERAPEUTIC GROUP:
vildagliptin - dipeptidyl-peptidase-4 (DPP-4) inhibitor.
metformin - biguanides.
Type 2 diabetes develops when the body does not produce enough
insulin, or when the
insulin that the body produces does not work properly or when the body
produces too
much glucagon.
Insulin is a substance which helps to lower the level of glucose in
the blood, especially
after meals. Glucagon is a su

خصائص المنتج

1
EUC API SEP22 V3 EU SmPC 07.2022
1. NAME OF THE MEDICINAL PRODUCT
Eucreas
®
50 mg/500 mg
Eucreas
®
50 mg/850 mg
Eucreas
®
50 mg/1000 mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50 mg of vildagliptin and 500, 850 or
1000 mg of metformin
hydrochloride.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
Eucreas 50 mg/500 mg: light yellow, ovaloid film-coated tablet,
bevelled edges, imprinted with
"NVR" on one side and "LLO" on the other side.
Eucreas 50 mg/850 mg: yellow, ovaloid film-coated tablet, bevelled
edges, imprinted with
“NVR” on one side and “SEH” on the other side.
Eucreas 50 mg/1000 mg: dark yellow, ovaloid film coated tablet,
bevelled edges, imprinted with
"NVR" on one side and "FLO" on the other side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Eucreas is indicated in the treatment of type 2 diabetes mellitus:
•
Eucreas is indicated in the treatment of adult patients who are unable
to achieve sufficient
glycaemic control at their maximally tolerated dose of oral metformin
alone or who are
already treated with the combination of vildagliptin and metformin as
separate tablets.
•
Eucreas is indicated in combination with a sulphonylurea (i.e. triple
combination therapy)
as an adjunct to diet and exercise in adult patients inadequately
controlled with
metformin and a sulphonylurea.
•
Eucreas is indicated in triple combination therapy with insulin as an
adjunct to diet and
exercise to improve glycaemic control in adult patients when insulin
at a stable dose and
metformin alone do not provide adequate glycaemic control.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
_with normal renal function (GFR ≥ 90 ml/min)_
_ _
The dose of antihyperglycaemic therapy with Eucreas should be
individualised on the basis of the
patient’s current regimen, effectiveness and tolerability while not
exceeding the maximum
2
EUC API SEP22 V3 EU SmPC 07.2022
recommended daily dose of 100 mg vildagliptin
.
Based o